Kornimate/medical-research-clean huggingface dataset:
continuous glucose sensing at the site of subcutaneous insulin administration

Conditions: Type 1 Diabetes

Summary: the study seeks to evaluate a novel treatment approach for performing continuous real-time glucose sensing and insulin delivery at the same subcutaneous tissue site.

the treatment of type 1 diabetes usually comprises the measurement of glucose in blood obtained by finger pricking and the administration of insulin via subcutaneous bolus injection or continuous subcutaneous infusion. this study seeks to test a new treatment approach where glucose sensing and insulin administration are combined and performed at a single subcutaneous tissue site (single-port treatment approach). a single-port device consisting of a continuous glucose sensor and an insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period. the performance of the single-port device is assessed by comparing the obtained glucose readings with those of a blood glucose meter and an additionally worn control sensor.

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age, both inclusive * type 1 diabetes treated with continuous subcutaneous insulin infusion (csii) * hba1c \< 10% * signed informed consent before any study-related activities exclusion criteria: * severe acute diseases * clinically overt diabetic complications * mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * taking of any vasoactive substances or anticoagulation medication * diseases of the skin which could interfere with application of the catheters and sensors as judged by the investigator * pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception. * increased tendency towards development of hypoglycaemia * any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject * concurrent participation in another study

Keywords: continuous glucose sensor subcutaneous insulin infusion closed-loop glucose control type 1 diabetes
effect of gw501516x on how the heart obtains and uses energy

Conditions: Dyslipidaemias; Heart Failure

Summary: the purpose of this study is to determine the effect of a 4-week treatment period with gw501516x on how the heart obtains and uses energy. the energy of the heart will be measured by magnetic resonance imaging (mri). this study will also measure a number of other potential markers of drug activity, including levels of certain lipids (fats) and proteins in your blood. the data from this study may help researchers better understand the actions of this drug in the body and if this drug may be useful to treat patients with heart disease.


Eligibility criteria:
inclusion criteria: * non-smoking. * body mass index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches). exclusion criteria: * history of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease). * documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.

Keywords: peroxisome proliferator activated receptors, ppars, heart failure, cardiac energetics, mri, gw501516x fatty acid metabolism,
connecting periodontal and coronary artery disease via the inflammatory state of the body

Conditions: Periodontal Diseases; Cardiovascular Diseases

Summary: cardiovascular disease is one of the leading causes of death in the united states and the world. many interventions relating to prevention have been emphasized as more risk factors for this devastating disease are discovered. periodontal disease is known to have a close association with cardiovascular disease, but its role as a risk factor is still not well understood. inflammation is a driving force in both of these diseases, creating a potential bridge between the two. specifically, periodontal disease can cause an inflammatory reaction in the body, which may predispose or even directly contribute to atheroma formation in the coronary arteries. in this study, the investigators will study the link between the inflammatory state of the body and will search for a correlation with levels of coronary artery disease and periodontal disease. inflammatory markers such as high-sensitivity c-reactive protein (hs-crp), erythrocyte sedimentation rate (esr), and immunoglobulin g (igg) levels in the patient's blood will be analyzed and correlated to clinical attachment loss measured via pocket depth measurement, the distance from the gingival margin to the base of the pocket. a definitive link between these disease processes will allow preventive measures to be taken earlier to prevent this lifelong disease.

dental probes will be used to probe depth of gum recession in subjects with and without a history of cardiac events. venous blood samples will also be collected from all subjects for measurement of sedimentation rate, myeloperoxidase, and igg levels. statistical analysis will then be done, in attempt to identify a difference in gum recession depth and/or serum inflammatory markers among those with and without prior cardiac events.

Eligibility criteria:
inclusion criteria: 1. patients with known cad with previous mi, or 2. patients without known cad 3. ages 18-89 years 4. patients who have dental implants with a recorded patient history of how the teeth were lost 5. patients with at least one tooth in each of the four quadrants of the mouth 6. able to obtain all necessary pocket measurements and blood samples needed for the study exclusion criteria: 1. patients with a known history of rheumatoid arthritis 2. patients with a known history of lupus 3. patients currently under the care of a rheumatologist 4. patients who have had a mi in the two weeks prior to entering the study 5. patients with a previous history of coronary artery bypass graft 6. current smokers and tobacco users 7. patients on disease-modifying agents for rheumatoid arthritis (methotrexate)10. patients who have undergone chemotherapy in the past five years 8. patients who currently use steroids or immunosuppressive agents
fast (focused abbreviated screening technique)-mri study

Conditions: Hepatocellular Carcinoma (HCC); Liver Cirrhosis

Summary: the purpose of this study is to compare the diagnostic value of a reconstructed abbreviated magnetic resonance imaging (mri) from a full clinical exam, compared to ultrasound (us) for screening of liver cancer. blood markers will be evaluated to determine their correlation to imaging. this study will help to determine whether abbreviated mri is superior to ultrasound for diagnosis of liver cancer.

hepatocellular carcinoma (hcc) is the fastest growing cause of cancer death in the united states and now kills over 30,000 americans annually. to reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for hcc, to detect hcc nodules when they are small and treatable. unfortunately, us has poor sensitivity for early-stage hcc in cirrhosis, failing to detect treatable cancer in over half of affected patients. alternatives such as computed tomography (ct) or magnetic resonance imaging (mri) are also not ideal due to ionizing radiation (ct), higher cost (mri), or long exam time (\~30-45 min for mri). an optimal and fast hcc screening method is urgently needed and should be more sensitive and cost-effective than us and avoid ionizing radiation. this is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 american centers as follows: icahn school of medicine at mount sinai-ismms, university of california san diego-ucsd, university of wisconsin-uw, and duke university. the composite reference standard will incorporate the clinical results of the full baseline mri exam and of subsequent imaging and pathology data collected over the next 6 months. routine clinical follow-up imaging at 6 months will be observed. patients will then be classified as positive for hcc, negative for hcc, or excluded.

Eligibility criteria:
inclusion criteria * liver cirrhosis of any etiology. * 18 years of age and older. * enrolled in screening/surveillance program for hcc. * clinically indicated imaging-based screening for hcc. * willing and able to complete all study procedures within specified time windows. * patient is able to give informed consent for this study. exclusion criteria * contra-indications to mri. * age less than 18 years. * patients with chronic renal failure or inability to tolerate contrast. * inability to undergo mri due to lack of insurance coverage. * prior negative screening exam less than 5 months prior to enrollment. * prior hepatic resection. * post liver transplantation. * previously treated hcc or other liver neoplasm. * any other condition or factor that in judgment of study investigator may interfere with study completion.

Keywords: magnetic resonance imaging (mri) ultrasound (us) liver diseases elastography
e-nose utility in the diagnosis of bacterial infection in copd

Conditions: Pulmonary Disease, Chronic Obstructive (COPD)

Summary: hypothesis: a commercial e-nose (cyranose 320) is able to detect specific breathprints from patients with copd and bacterial infection

thirty to 50% of copd patients have airway colonization with potentially pathogenic bacteria. this is associated with worse prognosis. currently, diagnosis of bacterial colonization relies mainly upon quantitative sputum culture. however, this method lacks good sensitivity. the electronic nose is a novel device made up of nanosensors capable of detecting specific volatile organic compounds (vocs). objectives: main 1) to assess the usefulness of the electronic nose in the diagnosis of bacterial colonization in copd. secondary 1) to define the vocs pattern associated with bacterial colonization. 2) to study the pattern of pulmonary and systemic inflammation associated with bacterial colonization as well its relationship with the aforementioned vocs patterns.

Eligibility criteria:
inclusion criteria: * copd patients exclusion criteria: * exacerbation in the last 4 weeks
novel strategies for innovating deceased donor procurement

Conditions: Kidney Failure, Chronic

Summary: despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. in addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. by innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. in this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.


Eligibility criteria:
inclusion criteria: 1. currently listed to receive a deceased donor kidney transplant 2. able to fully understand the informed consent document 3. recipient over the age of 18 years exclusion criteria: 1. recipients undergoing a bilateral native nephrectomy at time of transplant 2. recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant 3. individuals who are unable to understand the informed consent document 4. recipient under age 18 years 5. recipients receiving desensitization protocols for high levels of donor specific antibodies
effect of digital versus static jaw relation record on crestal bone changes around implants supporting maxillary single overdenture

Conditions: Edentulous Jaw

Summary: patients will be equally and randomly divided into 2 groups. each group contains seven patients: digital group: implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation. static group: implant supported maxillary overdenture will be constructed using the conventional jaw relation method. radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique. all data of radiographic evaluation were collected and tabulated then statistically analyzed using spss software.

* conventional single upper denture will be made for all patients. * occlusal adjustment of lower teeth for all patients by t-scan using the single upper conventional denture. * the single maxillary denture will be duplicated with radiopaque markers and cbct will be used to determine the exact positions of the implants. surgical procedures 1. surgery will be done under local anesthesia. 2. drilling will be carried out under copious sterile irrigation. 3. four implants will be inserted in canines and second premolar area in the maxilla. after 3-4 months of implants placement, patients will be equally and randomly divided into 2 groups. each group contains seven patients: digital group: for this group, implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation. static group: for this group, implant supported maxillary overdenture will be constructed using the conventional jaw relation method. post insertion: * clinical evaluation for any signs of inflammation is made. * further occlusal refining of lower teeth by t-scan is done with final overdenture. method of evaluation: radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique. all data of radiographic evaluation were collected and tabulated then statistically analyzed using spss software.

Eligibility criteria:
inclusion criteria: * age: under 60 years. * completely edentulous maxillary arch. * opposing natural dentition in the mandibular arch. * residual mandibular ridge has adequate bone and covered by firm healthy mucosa. * class i maxillary-mandibular relationship. * normal salivary flow with normal viscosity. * systemically free patients. exclusion criteria: * patients with poor oral hygiene. * patients with abnormal oral habits as (bruxism, clenching, tongue thrusting). * bone or mucosal diseases. * metabolic diseases or uncontrolled diabetes and tmj disorders. * conditions that may complicate the treatment like; large tongue, gagging reflex and limited mouth opening. * patients who are smokers.
effect of matrices on serum fructose.

Conditions: Fructose Metabolism Disorder

Summary: epidemiological evidence is accumulating that a high consumption of added sugars is associated with metabolic diseases such as non-alcoholic fatty liver disease and type 2 diabetes. fructose, one of the principal added sugars, is believed to be the most disadvantageous sugar. data from a large population-based cohort demonstrated that fructose intake from fruit juice and sugar-sweetened beverages, but not whole fruits, is associated with higher intrahepatic lipid content. a study in mice demonstrated that fast fructose exposure resulted in higher intrahepatic lipid content than slow fructose exposure. the food matrix, i.e. the complex spatial organisation of and interactions between nutrients, may account for the fast versus slow fructose exposure and subsequent health consequences. therefore the investigators aim to investigate the role of the fructose matrices on serum fructose peaks. the investigators hypothesize that liquid fructose matrices will cause higher serum fructose peaks in comparison to solid fructose matrices. objective: to quantify serum fructose peaks within 150 minutes following intake of fructose-containing matrices.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * body mass index (bmi) ≥18.5 kg/m2 and \<25 kg/m2 exclusion criteria: * pregnancy. * drugs and/or alcohol abuse. * diagnosis of diabetes mellitus. * (history of) gastrointestinal and/or liver disease. * (history \[\< 5 years\] of) cancer (excluding basal cell carcinoma) * physical stress one month prior to inclusion (i.e. post-surgery, trauma that requires medical treatment, bacterial/viral/fungal infection or extreme psychological stress). symptoms of infection include: fever, (excessive) sweating \& chills, cough, sore throat, shortness of breath, nasal congestion, diarrhea, vomiting, painful miction, redness/swelling, stomach ache, head ache, and stiff neck. * unstable weight for 3 months prior to inclusion (i.e. 5% change in bodyweight) * allergy to one of the used food products in the study. * inability to provide written informed consent.
ec_italynch: mainstreaming the diagnosis of lynch syndrome

Conditions: Lynch Syndrome; Endometrial Cancer

Summary: lynch syndrome (ls) is the most common cause of hereditary endometrial cancer (ec) and is associated with an increased risk of colorectal (crc), ovarian, gastric, small bowel and urinary tract cancer. ls is determined by germline pathogenic variants in the dna mismatch repair (mmr) genes (mlh1, msh2, msh6, pms2) or in epcam. approximately 20-30% of ecs exhibit somatic mmr deficiency (dmmr), and among these patients approximately 10-30% are affected by ls. this estimate suggests that the prevalence of ls among all ec patients is roughly 3-5%. prior to the introduction of universal screening, the diagnostic management of ls was mainly based on selective screening, which included clinical criteria based on the evaluation of family and personal history and the clinicopathological features of the tumor (amsterdam criteria 1990, bethesda criteria 1997). however, these have been limited in their application to clinical practice due to their complexity and the frequent lack of complete family history data. therefore, universal screening for ls diagnosis by the identification of dmmr in the tumor tissue of all newly diagnosed crc and ec cases has recently been proposed. universal screening for ls in tumor tissue includes an immunohistochemistry based (ihc) test to assess loss of mmr protein expression or a polymerase chain reaction (pcr) test for microsatellite instability. in the traditional diagnostic pathway for ls, genetic counseling and testing are always recommended for ec patients who are found to have loss of expression of any of the proteins encoded by the msh2, msh6, or pms2. in case of mlh1 loss, genetic counseling and genetic testing are recommended for patients without hypermethylation of the mlh1 promoter. recent findings suggest that incorporating genetic testing in an oncologist-driven diagnostic algorithm (mainstreaming of genetic testing) could enable increased diagnostic rates, offering the benefits of precision medicine and a streamlined pathway of care to patients and their families. the study consists of two parts: 1. in the first part the aim of the current study is to compare the knowledge, experience and understanding of genetic testing among patients pursuing genetic testing using mainstreaming or standard genetic counseling through modified modified royal marsden patient satisfaction questionnaire. 2. if the first aim will be achieved, a second part will be conducted, to evaluate the feasibility of the mainstreaming diagnostic pathway for ls.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of stage i-iv ec with dmmr 2. only for part i presence of lynch alert. 3. signed informed consent to participate in the study. 4. d. patient must be ≥18 years exclusion criteria: 1. histologically confirmed diagnosis of stage i-iv ec with pmmr. 2. significant psychiatric or clinical impairment compromising consent to the study.
evaluation of bevacizumab in combination with first-line chemotherapy in patients aged 75 years of older with metastatic colorectal adenocarcinoma (prodige20)

Conditions: Metastatic Colorectal Adenocarcinoma

Summary: to evaluate tolerance to and efficacy of bevacizumab in the treatment of mcrc in elderly patients, we propose a phase ii randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of mcrc in patients aged 75 years and older. this study is destined to continue as a phase iii trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.


Eligibility criteria:
inclusion criteria: * patients aged 75 years or older * ecog ≤2 * histologically proven unresectable metastatic colorectal adenocarcinoma * measurable lesion according to recist criteria * absence of prior chemotherapy for metastatic disease. adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously * patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the inr can be ensured. a change to low-molecular-weight heparin is preferable as long as the indications are respected * completed geriatric self-questionnaire * completed "team" geriatric questionnaire (including spitzer qol index) * written informed consent exclusion criteria: * estimated life expectancy \< 3 months * non-resolved intestinal occlusion or sub-occlusion * cerebral metastasis * other evolutive malignant tumor (non-stabilized cancer for less than 2 years) * evolutive gastroduodenal ulcer, wound or bone fracture * active heart disease: uncontrolled hypertension, myocardial infarction in the previous 6 months, angina, non-compensated congestive heart failure * major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment * polynuclear neutrophils \ 1g * history of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab * history of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab * history of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab * impossibility to ensure regular follow-up
a pilot study to evaluate the efficacy and safety of ariva® silver wintergreen in healthy smokers

Conditions: Tobacco Use Disorder; Smoking

Summary: study to determine the safety and effectiveness of silver salt in ariva® silver wintergreen lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.

each subject will be given an ariva® silver wintergreen lozenge or an ariva® wintergreen lozenge on a random basis. once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette. after a washout period, each subject will repeat the steps with the second type of lozenge.

Eligibility criteria:
inclusion criteria: * healthy adult smoker * smoking for at least 5 years * smoking at least one (1) pack of cigarettes a day * interest in quitting smoking exclusion criteria: * known allergy to silver or silver salts * pregnant or breast-feeding * current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study

Keywords: smoking smokeless aversion nicotine nicotine replacement